Phase 1 Brain Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have a confirmed brain tumour diagnosis of a specific type of glioma (grade 2–4), identified by laboratory testing as IDH1 R132H-wildtype, including types such as glioblastoma, diffuse astrocytoma, diffuse midline glioma, or related types
• People whose tumour tissue sample (from surgery or biopsy done before radiation) tested positive for a specific protein marker called PSMA, confirmed by a laboratory staining method
• People who have already completed standard treatment, including surgery (if the tumour could be removed) and a course of radiation therapy for their brain tumour
• People who have been on a low dose of a steroid medication (dexamethasone or equivalent, 4 mg or less per day) for at least 5 days before the first planned treatment in the trial
• People aged 18 or older
• People whose general physical functioning is at a level of 0, 1, or 2 on a standard medical scale (ECOG scale) — meaning they are able to carry out at least some daily activities (confirm with trial site)
• People whose kidneys are working at an adequate level, based on blood test results
• People whose liver is functioning at an adequate level, based on blood test results
• People whose blood counts (white blood cells, platelets, and haemoglobin) are within acceptable ranges based on blood tests
• People who are able and willing to use adequate contraception before joining the trial
• People who are able to understand the trial information and are willing to sign a consent form

Who may not be able to join:

• People whose tumour carries a different type of IDH mutation (other than the R132H type)
• People whose tumour is located within 5 mm of the brainstem, the optic chiasm, or the optic nerves
• People who received a medication called bevacizumab as part of their initial glioma treatment
• People with a life expectancy of less than 12 weeks
• People with a wound, ulcer, or bone fracture that is not healing
• People with a history of severe brain injury
• People who are not able to have repeated MRI scans during the trial
• People who have previously had radiation to more than 25% of their skeleton, or who have been treated with certain radioactive compounds (Radium-223, Strontium-89, or Samarium-153)
• People who have or have had another cancer whose history or treatment could interfere with assessing the safety or effectiveness of this trial's treatment
• People who are unable to tolerate the specialised imaging scans required (PSMA PET/MR or PSMA PET/CT)
• People with a history of viral hepatitis or chronic liver disease with active symptoms
• People with a history of problems affecting the pituitary or adrenal glands
• People with a previously diagnosed active infection, such as HIV or viral hepatitis
• People currently taking part in another clinical trial or receiving another investigational treatment
• People with known allergies or sensitivities to the trial drugs (68Ga-PSMA-11 or 177Lu-PSMA-617) or their components
• People who are currently pregnant or planning to become pregnant
• People who are unwilling to follow the trial's detailed contraception requirements
• People who have any other condition that, in the medical team's judgement, would make participation unsuitable

Important: Always verify eligibility with the trial site directly before applying.